POLYTECH Health & Aesthetics GmbH
DE-MF-000018836 · Germany · Dieburg
POLYTECH Health & Aesthetics GmbH is registered in the European database on medical devices as a manufacturer, with 4 795 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 3 558 |
|---|---|
| Class IIa | 913 |
| Class IIb | 324 |
Most frequent device types declared: Body contouring implant, Breast expander, Delivery sleeves, Mammary implant, Sizer.
Among these devices, 4 795 are declared sterile, 3 882 implantable.
Catalogue references include 15634-065, 15637-665, 15744-220, 20301-360H, 20647-145, 21631-575.
European nomenclature codes declared: P0601020202, P9099, P0601020299, P060299, P0601010202, P0601010201.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 4 795 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 4 795 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. POLYTECH Health & Aesthetics GmbH was not found in either the U.S. or the Canadian register.